BioLumix Exhibits at 2013 PDA Annual Meeting in Orlando, FL

This year’s Annual PDA Meeting –will be held in sunny Orlando at The Peabody Hotel, April 15-17th.  This meeting focuses mainly on present-day manufacturing, challenges in the industry, and those we will face in the future.  The meeting is separated into three tracks so each attendee may pick and choose different areas to learn more about.  Additionally, several planned networking and social activities will bring all kinds of professionals together to ask questions, learn and get to know one another.

FDA Approval - Drug Master FileAttendees will have an opportunity to visit the BioLumix booth – # 404.  The BioLumix System is a rapid, automated microbiological method that is the only system capable of concurrently testing both USP <61> and <62>.  The system provides a single platform for testing raw materials, in-process, finished product, environmental swabbing and processing water.  BioLumix provides a complete screening solution with real-time communication for early warning of contaminated samples (in hours rather than days), results for bacteria in 12-24 hours and Yeast & Mold in less than 48 hours.  Once all testing is complete, an automated Certificate of Analysis is available and can be printed via the printer or connected to a LIMS system.

The BioLumix system, as described in the “Encyclopedia of Microbiological Methods Volume 4” edited by Dr. Michael Miller’s, in Chapter 7, simultaneously detects microbial growth, provides an estimation of viable cell counts and identifies the presence of specified microorganisms.  Additionally, BioLumix has contributed Chapter 14 of “Environmental Monitoring,” edited by Jeanne Moldenhauer, “Validation of a Rapid System for Environmental Monitoring and Water Testing.”  Both books will be available to review at the BioLumix booth #404.

By encompassing both USP chapters (61 and 62), the BioLumix is the all-in-one microbial testing solution for companies looking to save significant time, labor and resources.  The system will bring automation to the current microbial testing! The system is based on optical sensors that detect color of fluorescent changes in ready to use carbon dioxide sensing vials.  These vials eliminate the need to make, prepare and QC traditional media.

BioLumix has a DMF (Drug Master File) on file with the FDA for prescription pharmaceuticals.  For OTC (Over the Counter) products, the system is fully Validatable.  BioLumix installers will generate the IQ (Installation Qualification) and OQ (Operation Qualification) on-site during the 2 ½ day training session.  We will also work with your team to complete the side-by-side testing portion of the PQ (Performance Qualification), leaving your company with a complete Validation package.

Please stop by Booth #404 to speak with a BioLumix expert, view our recent publications, ask questions, get answers and join the growing customer base of BioLumix users! Learn how BioLumix Rapid Microbiology can deliver significant reduction in time to results, reduced staff involvement, leading to faster product release. . . and how these can impact your key “operational profit drivers.” We look forward to earning another satisfied customer.  See you soon at the PDA Annual Meeting!

Everything is New at SupplySide Marketplace 2012!

New venue…new location…Stop by and see what’s new at BioLumix – booth #542 at the SupplySide Marketplace, Javits Center New York City on May 9th & 10th. The BioLumixsystem is the most advanced microbiological testing system of its kind. A demo of theBioLumix system will be available during the tradeshow.

Do you need Validated, Simplified Rapid Microbiology Testing? The state-of-the-art BioLumix system helps streamline microbial testing, and allows for easy compliance with cGMP, with over 200 instruments performing assays daily. All of BioLumix customers’ audits by FDA and NSF passed their inspection while using the BioLumix System.

Dealing with difficult to read plates or manual data transfer is a thing of the past. With automated monitoring of ready-to-use assay vials and automated data processing and archiving (paperless), the microbiologist’s job isa lot easier, with the same accurate results inless than half the time.

What is the BioLumix System? Test vials areincubated and the assay are monitored every 6 minutes. Each Instrument is capable of simultaneously running 32 test vials at one temperature. The modular structure of the BioLumix System enables flexible growth as needed; up to 1,024 samples can be tested simultaneously with up to 32 instruments connected to a single PC. There is random access to all instrument vial positions at any time. Therefore,no batching is required.

The Biolumix System is designed to accelerate product release with a simplified, automated approach.This yields fast, accurate results while reducing costs. No more waiting days for completed assays. The BioLumix System brings automated microbiological testing in house with most assay results achieved over night, and an Automated Certificate of Analysis within 48 hours for all USP assays. It is simple enough to be operated by no-microbiologists, providing accurate data of raw materials, environmental samples, and finished products.

What would you like to save? Time, money, labor? BioLumix does it all. The BioLumix system is both simple and cost-effective, with its streamlined testing design and single platform testing. The system is designed to accelerate product release using a modified simple methodology. It saves time to results,labor for microbiological testing and money due to its cost effectiveness. In many cases, return oninvestment is takes less than 6 months.

What would you like to test? Tablets, capsules, oils, liquids and powders are easily analyzed andresults are obtained quickly and with real time communication. The simple sample preparation allowstesting for raw materials, in-process product, finished goods, processing water and environmenta ltesting. All of which have been Validated by us, according to USP methodology, so you don’t have to. Infact, we are so excited about our system that we ask your company to send us samples and we will testthem for free so you can see the results!

What Assays would you like to test?

•••••••••

Total Aerobic Microbial Count Total Combined Mold and Yeast Count Enterobacterial Count (Bile-Tolerant Gram Negative Bacteria) ColiformE. coli Pseudomonas aeruginosa Staphylococcus aureus Salmonella Probiotic

Would you like No Product Interference?

The vial design is separated into two zones: the incubation zone where the sample is present, and the detection zone where the readings take place.Therefore, the system prevents any product Interference.

The BioLumix Advantage is:

•••••••••••••

Simplified testing procedures – can be operated by non microbiologists Ready to us vials-shorter sample preparationVial design prevents product interference Real-time communication for immediate action Early warning of contaminated samples An automated Certificate of Analysis within 48 hours including all organisms required by USP Validation package against USP methodology including IQ, OQ and PQ Allows for cost effective internalization of microbiological assays 21 CFR part 11 compliant with audit trail and login/ log out Centralized test data automatically stored and protected Cost reduction of microbiological assays Automation and connectivity – faster product release Allows internalization of microbiological testing
Come See Us at Booth #542!

Back to Back: BioLumix Attends Nutracon, Engredea and will be Featured in the Innovation Station during Engredea

Where & When?

March 7th-8th, BioLumix will be attending Nutracon at the Anaheim Hilton hotel for the first time ever in 2012, due to overwhelmingly positive feedback from both our customers and prospective customers about the show. Shortly after the Nutracon show, BioLumix will take its place in Booth #321 for the three day show, Engredea, March 9th – 11th. During this time, BioLumix will be featured at the Innovation Station located within the Engredea show floor.

Are cGMP Regulations Driving Up Your Costs?

Learn how we can save you time and money! Streamline your microbiological testing, reduce cost, increase efficiency and see rapid return on investment with the BioLumix system. BioLumix is fully automated, validated against US methodology, 21 CFR Part 11 Compliant system that allows for Complete microbiology testing results within 24-48 hours, allowing for faster product release time, shorter sample prep time – saving time, money and other resources. BioLumix was chosen as one of the most significant innovations in Engredea 2012-Don’t miss us at the innovation station

Why Visit us at Booth #321?

Be sure to stop by the BioLumix booth (#321) to view a product demo, meet some of our customers to learn the benefits that the system brought to them and inquire about our show special pricing. Examine our numerous product literature and scientific white papers.

The BioLumix System is completely modular, able to handle the microbiological testing needs of both large and small companies. In most cases a Return-On-Investment can be proved within 6 months. We truly believe the BioLumix System will make your company more efficient and add profits to your bottom line! Don’t just take our word for it, speak to our customers directly.

Are cGMP Regulations driving up your Costs? Find out how to reduce your Microbiological testing Costs

For answers Visit BioLumix at booth 21017 @ SupplySide West 2011 in Las Vegas

Since the completion of implementation of the cGMP’s for Nutraceutical Companies, all manufacturers must test their products for microbiology quality assurance and generate a certificate of analysis for each batch.  The products need to be tested in accordance with the methods described in USP <2021> and <2022>. Products need to be tested for Total Aerobic Microbial Count, Total Combined Mold and Yeast, Bile-Tolerant-Gram-Negative bacteria, and objectionable organisms (absent in 10 grams of organism such as Salmonella, E. coli, and sometimes S. aureus).  The state of the art BioLumix system helps streamline microbial testing, and allows for easy compliance with cGMP. The System is designed to accelerate product release with a simplified, automated approach. This yields fast, accurate, real-time results while reducing costs.  No more waiting days for completed assays. 

The streamlined all-in-one system is capable of testing raw materials, finished product, environmental swabs and processing water, all on a single platform.  Additionally, the system offers simplified sample preparation, real-time communication and a complete automated Certificate of Analysis, including the completion of all assays in 48 hours.   Dealing with difficult to read plates or manual data transfer is a thing of the past. With automated monitoring of ready-to-use assay vials and automated data processing and archiving (paperless), the microbiologist‘s job got a lot easier with the same accurate results in less than half the time.  Real-time data communication: Early warning of contaminated samples as well as sample release information could be automatically communicated through your intranet, significantly improving your company’s efficiencies.  BioLumix system can be used to test powders, oils, enzymes, botanical material, tablets, capsules, powders and liquids easily and without product interference.

BioLumix trainers will provide each customer with a full and customized Validation book, during the two and a half days of on-site training and installation of the system, including installation qualification, Operation Qualification and Performance qualification.  A sample Validation book will be available for viewing while visiting the BioLumix booth during SupplySide West 2011.

With this internal automated microbiological system, customers have control over their testing, leading to accurate results and accelerated product release while reducing costs.  The BioLumix Advantage: 

-          All assays can be performed on one Automated Microbial testing system

-          Automated Certificate of Analysis within 48 hours including results of all assays

-          Can be operated by non-Microbiologist

-          Complies with FDA cGMP Regulations

-          System is fully Validated during system installation

-          Designed to accelerate product release

-          Fully automated data archiving

You can find BioLumix on social media pages Linked In, Twitter and Facebook.  Follow us, become a Fan or join a discussion on one of our pages.

October 2011 marks the 5th year of BioLumix to exhibit at SupplySide West in Las Vegas, NV.  This yearly convention is held at the Sands Expo Center in The Venetian Hotel & Casino.  The Exhibit show hall will open beginning Wednesday, October 12th from 10am – 5:30pm, and Thursday, October 13th from 10am – 5pm.  BioLumix will be exhibiting in booth #21017.  Be sure to stop by booth #21017 to inquire about our free product trial and current Show Special! Pick up literature or leave your contact information to find out more about how the system can help your company save.

SupplySide East May 3-4, 2011 Come and See Our BioLumix Exhibit

Another year has passed and Spring is finally here!  Shortly following our successful show at Supply Expo Westin in Anaheim, CA, BioLumix will be traveling across the country to exhibit at the SupplySide East tradeshow in Secaucus, NJ.  The show floor is open beginning May 3rd and closes on May 4th.  Come and see (booth #1520) how we are revolutionizing the way companies are conducting their microbiology testing.  We would like to invite you to stop by and pick up some information, speak with experts and check out the newest most innovative technology on the market for Microbiology testing. 

When visiting our booth, be sure to:

-          See a demonstration of the system

-          Check out the 48-hour automated Certificate of Analysis

-          Let us help you Calculate your Return on Investment

-          Ask about our referral program

-          View the Validation Book

-          Pick up copies of Scientific White Papers

-          Find out more information about our technology

-          Contact us about the Free Product Trial!

-          Get references from our current customers

-          Hear about available financing options

-          Ask about the show special!

Did you know that in a recent customer satisfaction survey, all of our customers would recommend us to their vendors, suppliers and customers.

With the BioLumix system, we can help your company internalize the microbiology testing.  If you already have an internal laboratory, we can help you save time and money by automating your testing! Many of our customers have gone through audits and we have received great feedback from them.

We welcome all of our customers to stop by and say hello!  If you are not yet a customer, we would love the opportunity to work with you.  Our jobs center around satisfying our customers and providing unparalleled support.  We would be happy to give you a demonstration of the system including testing your samples for free.  After all, we wouldn’t want to sell you a product that doesn’t work for you.  Still not convinced? We would be more than happy to give you customer referrals.

Again, we would love to see you at the show and show you how our system can become a perfect fit for your company!

See you at Booth #1520!